Drugs and Cosmetics Act, 1940- Sections 16 to 20

Chapter IV

MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS [i][AND COSMETICS]

16. Standards of quality.

16. Standards of quality.—[ii][(1) For the purposes of this Chapter, the expression “standard quality” means—

(a) in relation to a drug, that the drug complies with the standard set out in [iii][the Second Schedule], and

(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]

(2) The [iv][Central Government], after consultation with the Board and after giving by notification in the Official Gazette not less than three months' notice of its intention so to do, may by a like notification add to or otherwise amend [v][the Second Schedule] for the purposes of this Chapter, and thereupon [vi][the Second Schedule] shall be deemed to be amended accordingly.

17. Misbranded drugs.

[vii][17. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be misbranded,—

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or

(b) if it is not labelled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

17-A. Adulterated drugs.

17-A. Adulterated drugs.—For the purposes of this Chapter, a drug shall be deemed to be adulterated,—

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

17-B. Spurious drugs.

17-B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious,—

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

17-C. Misbranded cosmetics.

17-C. Misbranded cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded,—

(a) if it contains a colour which is not prescribed; or

(b) if it is not labelled in the prescribed manner; or

(c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

17-D. Spurious cosmetics.

17-D. Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,—

(a) if it is manufactured under a name which belongs to another cosmetic; or

(b) if it is an imitation of, or a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or

(c) if the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.]

17-E. Adulterated cosmetics.

[viii][17-E. Adulterated cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be adulterated,—

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.]

18. Prohibition of manufacture and sale of certain drugs and cosmetics.

18. Prohibition of manufacture and sale of certain drugs and cosmetics.—From such date[ix] as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on this behalf—

(a) manufacture for sale [x][or for distribution], or sell, or stock or exhibit [xi][or offer] for sale, or distribute—

[xii][(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;

[xiii][(ii) any cosmetic which is not of a standard quality, or is misbranded, adulterated or spurious;]

[xiv][(iii)  any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof [xv][the true formula or list of active ingredients contained in it together with the quantities thereof];]

(iv) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims [xvi][to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;

[xvii][(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder;]

(b) sell, or stock or exhibit [xviii][or offer] for sale, or distribute any drug [xix][or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;

(c) manufacture for sale [xx][or for distribution] or sell, or stock or exhibit [xxi][or offer] for sale, or distribute any drug [xxii][or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter:

Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis:

Provided further that the [xxiii][Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the manufacture for sale [xxiv][or for distribution, sale, stocking or exhibiting or offering for] sale or distribution of any drug or class of drugs not being of standard quality.

Explanation.—[xxv][* * *]

18-A. Disclosure of the name of the manufacturer, etc.

[xxvi][18-A. Disclosure of the name of the manufacturer, etc.—Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic.]

18-B. Maintenance of records and furnishing of information.

[xxvii][18-B. Maintenance of records and furnishing of information.—Every person holding a licence under clause (c) of Section 18 shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.]

19. Pleas.

19. Pleas.—(1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug [xxviii][or cosmetic] in respect of which the offence has been committed or of the circumstances of its manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.

(2) [xxix][For the purposes of Section 18 a drug shall not be deemed to be misbranded or adulterated [xxx][or spurious] or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below standard quality] only by reason of the fact that—

(a) there has been added thereto some innocuous substance or ingredient because the same is required for the manufacture or preparation of the drug [xxxi][or cosmetic] as an article of commerce in a state fit for carriage or consumption, and not to increase the bulk, weight or measure of the drug [xxxii][or cosmetic] or to conceal its inferior quality or other defects; or

[xxxiii][* * *]

(b) in the process of manufacture, preparation or conveyance some extraneous substance has unavoidably become intermixed with it: provided that this clause shall not apply in relation to any sale or distribution of the drug [xxxiv][or cosmetic] occurring after the vendor or distributor became aware of such intermixture.

[xxxv][(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall not be liable for a contravention of Section 18 if he proves—

(a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor or dealer thereof;

(b) that he did not know and could not, with reasonable diligence, have ascertained that the drug or cosmetic in any way contravened the provisions of that section; and

(c) that the drug or cosmetic, while in his possession, was properly stored and remained in the same state as when he acquired it.]

20. Government Analysts.

[xxxvi][20. Government Analysts.—(1) The State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas in the State and in respect of such drugs or [xxxvii][classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification.

(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or [xxxviii][classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification.

(3) Notwithstanding anything contained in sub-section (1) or sub-section (2), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving.

[xxxix][(4) No person who has any financial interest in the import, manufacture or sale of drugs or cosmetics shall be appointed to be a Government Analyst under sub-section (1) or sub-section (2) of this section.]

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